RecruitingNot ApplicableNCT05858437

Impact of Propionic Acid on Regulatory T Cell Function in Children With CKD

Impact of Propionic Acid on Regulatory T Cell Function in Children With Chronic Kidney Disease

Sponsor

Charite University, Berlin, Germany

Enrollment

16 participants

Start Date

Jan 15, 2024

Study Type

INTERVENTIONAL

Conditions

CKD (Chronic Kidney Disease) Stage 5D

Summary

Pro-Kids is a multi-center, double-blind, randomized and placebo-controlled intervention study in children with chronic kidney disease. The investigators address the effect of a dietary food supplementation of propionic acid on the immune system and the function of the intestinal barrier in CKD patients treated with hemodialysis.

Eligibility

Min Age: 12 YearsMax Age: 20 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether a short-chain fatty acid called propionic acid can improve the function of regulatory immune cells (called regulatory T cells) in children with severe kidney disease (stage 5 chronic kidney disease, CKD G5) who are on dialysis. Poorly functioning immune cells may contribute to inflammation and complications in these patients. **You may be eligible if...** - You are under 18 years old and weigh more than 30 kg - You have stage 5 CKD (the most severe stage) and are receiving regular hemodialysis for at least 3 months - Your condition has been stable recently - Your CKD began during childhood **You may NOT be eligible if...** - You have an acute infection - You have received immunosuppressive therapy in the last 12 weeks - You have taken antibiotics, probiotics, or prebiotics in the last 4 weeks - You were hospitalized recently or are expected to be hospitalized during the study - You have cancer, pregnancy, chronic gut or liver disease, or alcohol/drug abuse Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DIETARY_SUPPLEMENTSodium propionate

The patients will be randomized to PA or placebo intervention (2:1 randomization). After the intervention of 28 days, we conduct an open-label study phase, where all patients are offered a dietary supplement of PA for overall 12 weeks (8 additional weeks for the intervention group and 12 weeks for the placebo group). By doing so we are giving every patient the opportunity to take PA and benefit from the possible positive impact on immunsystem and intestinal barrier function.

OTHERPlacebo